Please use the editable template below for creating consent forms. All studies submitted to the IRRB for approval MUST include a consent form. Any research that involves minors (participants under the age of 18) should also have a signature line on this form for their parent/guardian or legally authorized representative. In addition to the consent form, any study not considered exempt must alsoobtain permission from the cooperating school/institution, if the research is not conducted on Morningside College premises. Permission can be in the form of an email sent from an administrator of the cooperating school/institution to the Principal Investigator, which is then uploaded to the IRRB submission site. You should delete this and all highlighted or bracketed [like this] text before submitting to the IRRB and before using it in your research. You may alter the formatting of this document (e.g.-margins, font size/type, etc) as long as you keep the key contents intact.

Morningside CollegeConsent to Participate in a

BIOMEDICAL Research Study

Title:[Insert Title of Study]

Faculty Sponsor Information: [Insert faculty course instructor/sponsor contact information, or delete if PI is faculty]

Principal Investigator:[Name of lead investigator]

Contact Information:[Email Address & phone #]

Co-Investigator(s):[List names of any co-investigators]

Statement of Research

It is a principle of biomedical research that a subject who is to participate in the research investigation of biomedical research must give his or her informed consent to such participation. This consent must be based on the understanding of the nature and risks of the treatment, equipment used, and procedures. This document provides information important for this understanding. Please take your time to make your decision. If at any time you have questions, please ask.

Introduction

You are invited to be in a research study about [insert general statement to summarize the research study].

How long will I be in the study?

[Describe total length of time in study, as well as how that time is spent, e.g. three 10-minute lab visits versus 1 at-home session]

What will happen during the study?

[Describe the procedures/process in chronological order, avoid any technical jargon.]

[Identify and explain any procedures that are experimental.]

[If the study involves surveys or questionnaires, include a statement that the subject is free to skip any questions that he/she would prefer not to answer.]

What are the risks of the study?

There may be some risks from being in this study. [Describe anything that is MORE than minimal risk** to the participant in the study, some risks may be better described as things that could make the subject “uncomfortable”, such a fatigue or embarrassment. There is no such thing as a risk-free study. If there are no known risks, state that there are “no foreseeable risks” to participating]

**Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

What are the benefits of this study?

You [may not/will not] benefit personally from being in this study. However, we hope that, in the future, other people might benefit from this study because [describe why others might benefit in the future in terms of the knowledge that will be gained]. [Compensation/extra credit is also a benefit and should described where/how it will be offered if applicable.]

What are the alternatives to participating in this study?

(note that this section is optional and may be deleted depending upon the study)

[Insert alternative treatments/procedures to participating in the research.]

Will I be paid for participating?

(note that this section is optional and may be deleted if no compensation is given)

[Describe the monetary compensation.]

What if I am injured as a result of this study?

No funds have been set aside to compensate you in the event of an injury. If you feel you have suffered a research-related injury, please contact [give investigators name] at [give telephone number.]

Is being in this study voluntary?

Your participation is voluntary. You may refuse to participate or you may discontinue your participation at any time without penalty or loss of benefits to which you are otherwise entitled. Your decision whether or not to participate will not affect your current or future relations with Morningside College[and insert the names of any other cooperating institutions]. [If the researcher is recruiting students in his/her course to be research subjects, give further details about the procedure for ensuring there will be no penalty to those who do not participate.]

Will my records be kept confidential?

The records of this study will be kept confidential to the extent permitted by law. In any report about this study that might be published, you will not be identified. Your study record may be reviewed to the extent permitted by law and by the Morningside College Institutional Review Board. An IRB is a group of people who review the research to protect your rights. [If other IRBs are involved, insert the names of the IRBs.]

[If activities are to be audio- or videotaped, describe the subject's right to review/edit the tapes, who will have access, if they will be used for educational purposes, and when they will be erased or destroyed.]

Whom may I contact if I have questions?

You may ask any questions you have now or later about this research. Please use the faculty sponsor and/or investigator contact information listed above to ask any questions you may have later.

If you have any questions regarding your rights as a participant in this research and/or concerns about

the study, or if you feel under any pressure to enroll or to continue to participate in this study, you may contact the Morningside College Internal Research Review Board and you may ask more questions about the study at any time. For questions please contact Dr. Jessica Pleuss, chair of the IRRB or 712-274-5292.

  • You may also call this number to discuss or report any problems, complaints, or concerns you have about this research study.
  • You may also call this number if you cannot reach research staff, or you wish to talk with someone who is independent of the research team.

FINAL LIABILITY WAIVER STATEMENT

I am willingly participating in this research. I’m aware of any risks and/or benefits involved. In the event that I experience an accident or medical emergency while participating in the research described above, I hereby give permission to the researchers to obtain medical treatment on my behalf. I agree that I will be responsible for any noted exceptions.

Statement of Consent

[Include only if applicable] I give consent to be audiotaped during this study.

Please initial: ____ Yes____ No

[Include only if applicable] I give consent to be videotaped during this study.

Please initial: ____ Yes____ No

[Include only if applicable] I give consent for my quotes to be used in the research; however I will not be identified.

Please initial: ____ Yes____ No

Your signature indicates that this research study has been explained to you, that your questions have been answered, and that you agree to take part in this study. You can receive a copy of this form if you desire.

Participant’s Name (Printed)______

______

Signature of ParticipantDate

[Only include the Parent/Guardian signature line IF APPLICABLE to your study

—otherwise delete this section]

Parent/Guardian or Legally Authorized Representative’s Name and Relationship to

Subject.

______

Name (Printed)Relationship to Participant

______

Signature of Parent/Guardian orDate

Legally Authorized Representative

[If you are not giving the consent in person, remove section below.]

Statement of Person Who Obtained Consent

I have discussed the above study with the participant or, when appropriate, with the participant’s legally authorized representative. It is my opinion that the participant adequately understands the risks, benefits, and procedures involved with participation in this research study.

______

Signature of Person Obtaining ConsentDate

Page 1 of 4